BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 3923266 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14558
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC FOR A ROUTINE FOLLOW-UP AND THE ATRIAL LEAD EXHIBITED A SENSING ANOMALY. THE LEAD ALSO EXHIBITED INTERMITTENT LOSS OF CAPTURE. THE LEAD REMAINED IMPLANTED AND THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402043 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR